The FDA’s record year of drug approvals — By the numbers

Jan 26, 2018

Last year, the FDA vowed to combat high drug prices by speeding up the approvals process for generic medications. Recently, the agency released numbers proving that its delivered on its promise.

Ultimately, 2017 was a record year in general for all approvals, including new medications. Under the leadership of FDA’s commissioner, Scott Gottlieb, the agency has taken proactive steps to streamline procedures for approvals, make the application process easier, engage with patient populations and give more medications “breakthrough therapy” designation status, which cuts review times.

Here’s a look at the FDA’s hallmark year, by the numbers.

1,027 = Generics approved in 2017 — the most in one year in the agency’s history. 

46 = 46 novel drugs approved by CDER either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics License Applications (BLAs)— CDER's highest rate in 21 years. Cancer medications got the most nods (16 new approvals), while 11 new drugs were in hematology and 11 were for infectious diseases. CDER identified 15 of the 46 novel drugs approved in 2017 as first-in-class. The total number (46) does not include the handful new gene therapies approved in 2017, which are treated as a separate category.  

22 = New drugs approved in 2016, a six-year low.

80 percent = The average number of drug applications submitted to the FDA for review that gain approval. Because that percentage has stayed consistent in recent years, some experts attribute the spike in 2017 to a higher number of drug approval applications — not just FDA policies.

200 = Backlogged requests for orphan drug designation that were eliminated in 2017 under the Orphan Drug Modernization Plan passed in August. Receiving orphan drug designation, which is aimed at medications that treat rare diseases, gives the developer a tax credit for clinical testing, encouraging pharmaceutical companies to make more new drugs.

About 7,000 = Medications that are currently in various stages of development in the pharmaceutical pipeline. 

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